Optimal designs for phase II/III drug development programs including methods for discounting of phase II results

被引:0
作者
Stella Erdmann
Marietta Kirchner
Heiko Götte
Meinhard Kieser
机构
[1] University of Heidelberg,Institute of Medical Biometry and Informatics
[2] Merck Healthcare KGaA,undefined
来源
BMC Medical Research Methodology | / 20卷
关键词
Optimization; Drug development program; Bias adjustment; Assurance; Probability of success; Sample size; Software;
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[1]  
DiMasi JA(1995)Research and development costs for new drugs by therapeutic category Pharmaco Economics 7 152-169
[2]  
Hansen RW(2010)Trends in risks associated with new drug development: success rates for investigational drugs Clinical Pharmacology & Therapeutics 87 272-277
[3]  
Grabowski HC(2020)Empowering phase II clinical trials to reduce phase III failures Pharm Stat 19 178-186
[4]  
Lasagna L(1988)Stopping rules and estimation problems in clinical trials Stat Med 7 1231-1242
[5]  
DiMasi JA(2004)Conditional bias of point estimates following a group sequential test J Biopharm Stat 14 505-530
[6]  
Feldman L(2012)Overestimation of the effect size in group sequential trials Clin Cancer Res 18 18,4872-18,4876
[7]  
Seckler A(2010)Bias and trials stopped early for benefit Jama. 304 156-159
[8]  
Wilson A(2013)Monitoring in clinical trials: benefit or bias? Theoretical Medicine and Bioethics 34 259-274
[9]  
De Martini D(2012)Assumptions of expected benefits in randomized phase III trials evaluating systemic treatments for cancer J Natl Cancer Inst 104 590-598
[10]  
Hughes MD(2011)Trial watch: phase II failures: 2008–2010 Nat Rev Drug Discov 10 328-329